Drug Approval | October 05, 2022
Casper Pharma receives EIR from USFDA for its PAI
The inspection concluded with no observation (FDA-483) issued.
The inspection concluded with no observation (FDA-483) issued.
Celgene agreed to provide Dr. Reddy's with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S.
This launch builds upon Hikma’s leading position as one of the largest US providers of nasally administered medicines used for treating seasonal allergies and advances its objective of growing its specialty business in the US
The RRA was conducted from 22nd August, 2022 to 26th August, 2022.
The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
Abbott has recently received the US Food and Drug Administration nod to use its DBS device for treatment-resistant depression
Sanofi will begin to ship their vaccines helping to ensure more people will be immunized
The objective of this Phase 1 study is to determine the safety and tolerability of OLX10212 in patients with advanced AMD at multiple sites in the US.
This multicenter, open-label Phase I study is designed to assess the safety and tolerability
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